Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
29/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr John Salmon

ORCID ID

Contact details

John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0203125674; N0199129912; N0176115690

Study information

Scientific title

A randomised trial of the effect of bleb site on eye comfort following trabeculectomy

Acronym

Study hypothesis

To investigate long-term post-operative eye discomfort following glaucoma surgery; in particular whether two different wound locations and therefore eye fluid drainage, differ in the level of eye comfort experienced as measured by a validated questionnaire, the 'Glaucoma Symptom Scale'.

On 14/07/2011 the following changes were made to this trial record:
1. The end date was changed from 31/12/2008 to 30/06/2010.
2. The target number of participants was changed from 40 to 150.
3. The trial was originally a multi-centre trial but due to recruitment issues at other centres the Oxford site proceeded single-handedly.

Ethics approval

Oxford Research Ethics Committee B, 10/09/2002, ref: C02.200

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery: Trabeculectomy

Intervention

The study design is a randomised trial designed to compare two accepted variations in surgical techniques of trabeculectomy and its effect on postoperative eye comfort. Patients who are undergoing first trabeculectomy will be approached to participate in the study. Patients will either be recruited in person or by invitation letter. When the patient gives written consent, they are randomised either to superior trabeculectomy or superonasal trabeculectomy. At the pre-operative visit they will answer a 10-question self-administered questionnaire, the Glaucoma Symptom Scale. Some pre-operative data will be collected on study forms identified only by hospital number and study number.

During the trabeculectomy, the bleb will be placed below the middle upper lid, or placed below the more inner upper lid.

After the trabeculectomy, usual medical care will take place uninfluenced by their participation in this study. At the 6-month post-operative visit, the patient will be examined for the study and a second Glaucoma Symptom Scale questionnaire will be completed by the patient. The examination will record clinical findings such as visual acuity, eye pressure and eye examination findings. The study ends here and patients continue their usual care.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

1. Eye comfort at 6 months post-surgery as measured by the Glaucoma Symptom Scale
2. Eye features associated with eye discomfort (dysesthesia) at 6 months post-surgery

Secondary outcome measures

No secondary outcome measures

Overall trial start date

10/09/2002

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years and over, either sex
2. Listed for trabeculectomy
3. Satisfy the inclusion criteria

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

10/09/2002

Recruitment end date

30/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Devon and Exeter NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Royal Berkshire and Battle Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Oxford Radcliffe Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes